Diagnosis of Renal Cell Carcinoma on 68Ga-PSMA PET-CT and Radioligand Therapy With 177Lu-EB-PSMA-617

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Renal Cell Carcinoma

Treatments: Drug: 68Ga-PSMA; Drug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617

Study type: Interventional

Funder types: Other

Identifiers

NCT05170555

PekingUMCHPSMARCC

Details and patient eligibility

About

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. Considering its origination from kidney, an organ with intense physiological uptake and excretion of 68Ga-PSMA, this study aims to evaluate the uptake of 68Ga-PSMA in RCC compared to 18F-FDG in the same patients, and assess the feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced RCC.

Full description

Renal Cell Carcinoma (RCC) is the second most common tumor in urology. As one of the popular urinary tumors, the incidence rate increases by 2-4% per year. Localized RCC is generally cured by surgery, which has achieved good efficacy. However, advanced RCC are still the main factors influencing the survival of RCC patients due to its intrinsic resistance to conventional chemotherapy or radiotherapy. 18F-FDG PET/CT is considered to be a viable tool to assess RCC at initial presentation. However, FDG uptake in RCC is lower than most other solid tumors and is indistinguishable from benign lesions. So, it is necessary to find another effective way to detect RCC and its metastases. As in known, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. 68Ga-PSMA has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be superior for diagnosis, therapy response assessment and follow-up of RCC than 18F-FDG PET/CT. Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with RCC.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed treated or untreated renal cell carcinoma patients;
• 68Ga-PSMA PET/CT and 18F-FDG PET/CT within two weeks;
• signed written consent.

Exclusion criteria

• pregnancy;
• breastfeeding;
• known allergy against PSMA
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

68Ga-PSMA, PET/CT and 177Lu-EB- PSMA-617 therapy

Experimental group

Description:

All patients diagnosed with RCC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.

Treatment:

Drug: 68Ga-PSMA

Drug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617